510(k) · Cleared
ClearedNO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc Washers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Sports Medicine · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 18, 2013 as substantially equivalent to K981967 (Arthrotek/Biomet, Inc., 1998) and 1 other predicate after a 434-day review. Its family tree reaches back 2 generations to 1987. 4 later devices descend from it.
- Decided
- Oct 18, 2013
- Review
- 434 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K871037 (1987). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK871037 Cancellous Fixation Screw & Washer for Use W/ScrewConcept, Inc. · 1987
- 1 generation backK981967 Washerloc Screw System, Ligament Screw System, NO-Profile…Arthrotek/Biomet, Inc. · 1998
- This deviceK122437 NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc…Biomet Sports Medicine · 2013
- Descendant · cites it directly · 3 of its ownK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · 3 generations on · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024
- Descendant · 3 generations on · 0 of its ownK230226 Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023
Most influential descendants
Showing 4 of 4 · See all- K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc. · 2020 · cites it directly3descendants
- K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · 2 generations on2descendants
- K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024 · 3 generations on0descendants
- K230226Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871037 | Cancellous Fixation Screw & Washer for Use W/Screw | Concept, Inc. | 1987 | — |
| −1 | K981967 | Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw… | Arthrotek/Biomet, Inc. | 1998 | — |
| 0 (this device) | K122437 | NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc Washers | Biomet Sports Medicine | 2013 | — |
| +1 | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw… | Biomet, Inc. | 2020 | — |
| +2 | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +3 | K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024 | — |
| +3 | K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981967 | Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System…Summary page 1…, Ligament Washer, Lo-Profile M , Heckman'", and to which equivalence is Channel Ligament Screw Systems - Biomet Sports Medicine claimed K981967 Cancellous Fixation Screw & Washer - Concept Inc., K(871037 Reason for 510(k) Add… | 1998 |
| * | K871037 | Cancellous Fixation Screw & Washer for Use W/ScrewSummary page 1…ment Screw Systems - Biomet Sports Medicine claimed K981967 Cancellous Fixation Screw & Washer - Concept Inc., K(871037 Reason for 510(k) Addition of magnetic resonance (MR) compatibility language to submission th… | 1987 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System… | 2020 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K193214 (Biomet, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K981967.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122437: NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc Washers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122437
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026